MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number S7

Device Problem Imprecision (1307)

Patient Problems Injury (2348); Iatrogenic Source (2498)

Event Date 10/04/2017

Event Type  Injury  

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.The representative was unable to replicate the reported issue.Following a discussion with the surgeon, it was suspected that the emitter for the navigation system moved during the procedure leading to the imprecision.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.

Event Description

A site representative reported that, while in a cranial biopsy, an imprecision was observed resulting in a pass being performed where no diagnostic tissue could be collected.It was reported that the navigation system displayed the biopsy needle to have been in the lesion.It was noted that a second pass, with a slightly different trajectory was successful.There was a reported delay to the procedure of less than 1 hour due to this issue.No additional information was provided.

Manufacturer Narrative

The software investigation found that the reported event was unrelated to a software issue.The software functioned as designed.

Manufacturer Narrative

Additional information: medtronic received information that the imprecision was a few millimeters as the trajectory angle was adjusted.

• Brand Name: STEALTHSTATION S7 SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: peter verhey ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 6997221
• MDR Text Key: 90901368
• Report Number: 1723170-2017-04436
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450968
• UDI-Public: 00613994450968
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: S7
• Device Catalogue Number: 9733858
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 70